15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PICC
FDA 510(k)
FDA Class 2
·General Hospital
HairCheck-DT (PCP)
FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
FDA 510(k)
FDA Class 2
·General Hospital
THE SALICEPT ORAL PATCH
FDA 510(k)
FDA Unclassified
·Unknown
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MEDINA·Product code FRN·April 4, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 9, 2013
CONTAK RENEWAL 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·April 6, 2011
Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·July 16, 2014
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012